127 results on '"Austermann, M."'
Search Results
2. Tortuosity is the Significant Predictive Factor for Renal Branch Occlusion after Branched Endovascular Aortic Aneurysm Repair
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Sugimoto, M., Panuccio, G., Bisdas, T., Berekoven, B., Torsello, G., and Austermann, M.
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- 2016
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3. Performance of Bridging Stent Grafts in Fenestrated and Branched Aortic Endografting
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Panuccio, G., Bisdas, T., Berekoven, B., Torsello, G., and Austermann, M.
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- 2015
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4. Juxtarenale Aortenaneurysmen: Komplementäre operative Therapieverfahren
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Austermann, M., Donas, K.P., Bosiers, M.J., and Torsello, G.
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- 2015
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5. Bilateral Use of Iliac Branch Devices for Aortoiliac Aneurysms Is Safe and Feasible, and Procedural Volume Does Not Seem to Affect Technical or Clinical Effectiveness: Early and Midterm Results From the pELVIS International Multicentric Registry
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D'Oria, M., Pitoulias, G. A., Torsello, G. F., Pitoulias, A. G., Fazzini, S., Masciello, F., Verzini, F., Donas, K. P., Taneva, G. T., Austermann, M., Bosiers, M., Dorigo, W., Cao, P., Ferrer, C., Ippoliti, A., Barbante, M., Parlani, G., Simonte, G., Kolbel, T., Tsilimparis, N., Haulon, S., Branzan, D., Schmidt, A., Pratesi, C., Fargion, A., Pratesi, G., D'Oria, M, Pitoulias, Ga, Torsello, Gf, Pitoulias, Ag, Fazzini, S, Masciello, F, Verzini, F, and Donas, Kp
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medicine.medical_specialty ,business.industry ,Clinical effectiveness ,medicine.disease ,Abdominal aortic aneurysm ,Center volume ,abdominal aortic aneurysm ,aortoiliac disease ,center volume ,iliac branch device ,Settore MED/22 ,medicine.anatomical_structure ,medicine ,Radiology, Nuclear Medicine and imaging ,Surgery ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Aortoiliac disease ,Pelvis ,Volume (compression) - Abstract
Objective To evaluate early and follow-up outcomes following bilateral use of iliac branch devices (IBD) for aortoiliac endografting and assess the impact of center volume. We used data from the pELVIS international multicentric registry. Methods For the purpose of this study, only those patients receiving concomitant bilateral IBD implantation were analyzed. To assess the impact that procedural volume of bilateral IBD implantation could have on early and follow-up outcomes, participating institutions were classified as Site(s) A if they had performed >10 and/or >20% concomitant bilateral IBD procedure, otherwise they were classified as Site(s) B. Endpoints of the analysis included early (ie, 30-day) mortality and morbidity, as well as all-cause and aneurysm-related mortality during follow-up. Additional endpoints that were evaluated included IBD-related reinterventions, IBD occlusion or stenosis requiring reintervention (ie, loss of primary patency), and IBD-related type I endoleak. Results Overall, 96 patients received bilateral IBD implantation (out of 910 procedures collected in the whole pELVIS cohort), of whom 65 were treated at Site A (ie, Group A) and 31 were treated at Site(s) B (ie, Group B). In total, only 1 death occurred within 30 days from bilateral IBD implantation, and 9 patients experienced at least 1 major complication without any significant difference between subjects in Group A versus those in Group B (10.8% vs 6.5%, p=0.714). In the overall cohort, the 2-year freedom from IBD-related type I endoleaks and IBD primary patency were 96% and 92%, respectively; no significant differences were seen in those rates between Group A or Group B (95% vs 100%, p=0.335; 93% vs 88%, p=0.470). Freedom from any IBD-related reinterventions was 83% at 2 years, with similar rates between study groups (85% vs 83%, p=0.904). Conclusions Within the pELVIS registry, concomitant bilateral IBD implantation is a safe and feasible technique for management of aortoiliac aneurysms in patients with suitable anatomy. Despite increased technical complexity, effectiveness of the repair is satisfactory with low rates of IBD-related adverse events at mid-term follow-up. Procedural volume does not seem to affect technical or clinical outcomes after bilateral use of IBD, which remains a favorable treatment option in selected patients.
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- 2021
6. The PROTAGORAS 2.0 Study to Identify Sizing and Planning Predictors for Optimal Outcomes in Abdominal Chimney Endovascular Procedures
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Fazzini, S., primary, Martinelli, O., additional, Torsello, G., additional, Austermann, M., additional, Pipitone, M.D., additional, Torsello, G.F., additional, Irace, L., additional, and Donas, K.P., additional
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- 2021
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7. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System
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Torsello, G.F., primary, Argyriou, A., additional, Stavroulakis, K., additional, Bosiers, M.J., additional, Austermann, M., additional, and Torsello, G.B., additional
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- 2020
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8. Iliac Branch Devices in Women: Results From the pELVIS Registry
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Soler, Raphael, primary, Charbonneau, Philippe, additional, Sobocinski, Jonathan, additional, Mougin, Justine, additional, Donas, Konstantinos P., additional, Torsello, Giovanni, additional, Fabre, Dominique, additional, Haulon, Stéphan, additional, Austermann, M., additional, Inchingolo, M., additional, Bisdas, T., additional, Pratesi, G., additional, Barbante, M., additional, Cao, P., additional, Ferrer, C., additional, Verzini, F., additional, Parlani, G., additional, Simonte, G., additional, Pratesi, C., additional, Fargion, A., additional, Masciello, F., additional, Kölbel, T., additional, Tsilimparis, N., additional, Haulon, S., additional, Branzan, D., additional, Schmidt, A., additional, and Scheinert, D., additional
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- 2020
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9. The impact of aortic remodeling on the performance of bridging stents after branched endovascular aortic repair
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Fazzini, S, Torsello, Gf, Austermann, M, and Torsello, G
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BEVAR ,REMODELING ,MIGRATION - Published
- 2019
10. Iliac Branch Devices in Women: Results From the pELVIS Registry
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Austermann, M., Inchingolo, M., Bisdas, T., Pratesi, G., Barbante, M., Cao, P., Ferrer, C., Verzini, F., Parlani, G., Simonte, G., Pratesi, C., Fargion, A., Masciello, F., Kölbel, T., Tsilimparis, N., Haulon, S., Branzan, D., Schmidt, A., Scheinert, D., Soler, Raphael, Charbonneau, Philippe, Sobocinski, Jonathan, Mougin, Justine, Donas, Konstantinos P., Torsello, Giovanni, Fabre, Dominique, and Haulon, Stéphan
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- 2020
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11. Tortuosity is the Significant Predictive Factor for Renal Branch Occlusion after Branched Endovascular Aortic Aneurysm Repair
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Sugimoto, M., primary, Panuccio, G., additional, Bisdas, T., additional, Berekoven, B., additional, Torsello, G., additional, and Austermann, M., additional
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- 2016
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12. Performance of Bridging Stent Grafts in Fenestrated and Branched Aortic Endografting
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Panuccio, G., primary, Bisdas, T., additional, Berekoven, B., additional, Torsello, G., additional, and Austermann, M., additional
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- 2015
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13. Juxtarenale Aortenaneurysmen
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Austermann, M., primary, Donas, K.P., additional, Bosiers, M.J., additional, and Torsello, G., additional
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- 2015
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14. Performance of Bridging Stent-grafts in Fenestrated and Branched Aortic Endografting
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Panuccio, G., primary, Bisdas, T., additional, Berekoven, B., additional, Torsello, G., additional, and Austermann, M., additional
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- 2014
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15. Wie effektiv ist eine lokale Antibiose beim Leistenzugang in der offenen Gefäßchirurgie?
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Schönefeld, E, Muratagic, A, Osada, N, Austermann, M, Torsello, G, Schönefeld, E, Muratagic, A, Osada, N, Austermann, M, and Torsello, G
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- 2011
16. Behandlung komplexer Aortenaneurysmen mittels fenestrierter Endoprothese – eine erste Bilanz
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Kienz, P., primary, Austermann, M., additional, Teßarek, J., additional, and Torsello, G., additional
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- 2010
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17. Lange femoro-popliteale Läsionen erfordern lange Stents – erste Erfahrungen mit 128 Protégé-Stents
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Schönefeld, E., primary, Schönefeld, T., additional, Osada, N., additional, Austermann, M., additional, and Torsello, G., additional
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- 2009
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18. JMangler - a framework for load-time transformation of Java class files.
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Kniesel, G., Costanza, P., and Austermann, M.
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- 2001
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19. Endovascular treatment of common iliac artery aneurysms using the bell-bottom technique: long-term results.
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Torsello G, Schönefeld E, Osada N, Austermann M, Pennekamp C, Donas KP, Torsello, Giovanni, Schönefeld, Eva, Osada, Nani, Austermann, Martin, Pennekamp, Corinna, and Donas, Konstantinos P
- Abstract
Purpose: To retrospectively evaluate the long-term outcome of the bell-bottom technique for the endovascular repair of common iliac artery (CIA) aneurysms.Methods: Between September 2003 and September 2008, 89 patients (84 men; mean age 73.7+/-8.4 years) with aortic and CIA aneurysms were treated at 2 European centers with aortic extension cuffs or large iliac limbs that gave a bell-bottom configuration to the iliac portion of an aortoiliac stent-graft. The mean maximum aortic diameter was 65.7+/-12.3 mm (range 42-98), and the mean diameter of the treated CIA aneurysms was 22.1+/-3.0 mm (range 20-30).Results: Technical success was achieved in 97.8% (87/89). There was no early (<30-day) mortality, but 8 (8.9%) patients died (none aneurysm-related) during follow-up. Cumulative survival by Kaplan-Meier analysis was 96.3% at 1 year, 85.5% at 3 years, and 83.1% at 5 years. After a mean follow-up of 56.5 months, computed tomography documented 3 (3.4%) type I endoleaks: one proximal leak was treated by conversion to open repair, and the other 2 distal type I endoleaks were treated by implantation of an iliac extension. Two (2.2%) type II endoleaks were accompanied by an increase in the aneurysm diameter; one was treated by coil embolization of the inferior mesenteric artery and the other by conversion to open repair after repeated coil embolization. One patient underwent thrombectomy for iliac limb occlusion. The freedom from secondary intervention was 91.6% at 5 years. The mean maximum diameter of the CIA aneurysms showed no significant change over time (24.1+/-3 mm at 30 days and 23.4+/-4 mm at latest follow-up).Conclusion: Moderate-size CIA aneurysms (<30 mm) can be safely and effectively treated using the bell-bottom technique. The risk of distal type I endoleak is low. Iliac-related complications can be successfully treated by endovascular techniques. [ABSTRACT FROM AUTHOR]- Published
- 2010
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20. Lange femoro-popliteale L�sionen erfordern lange Stents – erste Erfahrungen mit 128 Prot�g�-Stents.
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Sch�nefeld, E., Sch�nefeld, T., Osada, N., Austermann, M., and Torsello, G.
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- 2009
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21. JMangler - a framework for load-time transformation of Java class files
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Kniesel, G., primary, Costanza, P., additional, and Austermann, M., additional
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22. CT Angiography at 24 Months Demonstrates Durability of EVAR With the Use of Chimney Grafts for Pararenal Aortic Pathologies
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Mario Lachat, Dieter Mayer, Giovanni Torsello, Martin Austermann, Stefan Puchner, Zoran Rancic, Thomas Pfammatter, Felice Pecoraro, Theodosios Bisdas, Konstantinos P. Donas, Donas, KP, Pecoraro, F, Bisdas, T, Lachat, M, Torsello, G, Rancic, Z, Austermann, M, Mayer, D, Pfammatter, T, Puchner, S, University of Zurich, and Donas, Konstantinos P
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Male ,medicine.medical_specialty ,Time Factors ,medicine.medical_treatment ,Aortic Diseases ,610 Medicine & health ,Endovascular aneurysm repair ,2705 Cardiology and Cardiovascular Medicine ,Aortic aneurysm ,Aneurysm ,medicine.artery ,medicine ,Humans ,2741 Radiology, Nuclear Medicine and Imaging ,Radiology, Nuclear Medicine and imaging ,Aorta, Abdominal ,Embolization ,Superior mesenteric artery ,Aged ,endovascular aneurysm repair, chimney graft, periscope graft, pararenal aortic pathologies, aortic aneurysm, para-anastomotic aneurysm, ruptured aneurysm, stent-graft, balloon-expandable stent-graft, computed tomographic angiography, endoleak, renal arteries, superior mesenteric artery, sac shrinkage, sac expansion ,medicine.diagnostic_test ,10042 Clinic for Diagnostic and Interventional Radiology ,business.industry ,Endovascular Procedures ,Angiography ,Perioperative ,medicine.disease ,Blood Vessel Prosthesis ,10020 Clinic for Cardiac Surgery ,2746 Surgery ,Surgery ,Cuff ,Female ,Stents ,Radiology ,Tomography, X-Ray Computed ,Cardiology and Cardiovascular Medicine ,business ,Follow-Up Studies - Abstract
PURPOSE: To present the 24-month radiological follow-up data for patients with pararenal aortic pathologies treated with chimney and periscope grafts during endovascular repair. METHODS: Between January 2008 and December 2011, 124 high-risk patients with complex pararenal aortic pathologies were treated using the chimney technique at 2 European vascular and cardiovascular centers with advanced experience of the described technique. In particular, 50 patients were treated at Site 1 and 74 at Site 2. Forty (32.2%) patients (32 men; mean age 79.2±4.9 years) completed computed tomographic angiography follow-up at 24 months postoperatively. RESULTS: The overall technical success was 100%, and the early- and midterm procedure-related mortality was 0%. Three (2.4%) patients had a perioperative type Ia endoleak that persisted; two were treated by transbrachial perigraft embolization and cuff implantation. The last patient is under radiological surveillance due to a "low-flow" type Ia endoleak and stable sac size. A type II endoleak was detected in 7 (5.6%) patients. During the 2-year follow-up, significant shrinkage (>5 mm; n=22) or stable aneurysm diameter (n=14) was seen in 36 (90%) of the cases. Overall, mean aneurysm sac shrinkage was 12% (p=0.002) and 10% (p=0.014) for the 2 centers, respectively (overall p=0.008). The causes for sac progression in the 4 (10%) patients were a type Ia endoleak, 2 type II endoleaks, and endotension. CONCLUSION: The present study demonstrates that the use of chimney and/or periscope endografts for pararenal aortic pathologies achieves and maintains successful exclusion of the aneurysm in 90% of the cases at 24 months of radiological follow-up. In centers experienced with this approach, the chimney technique may represent a reliable therapeutic modality in selected patients.
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- 2013
23. Use of covered chimney stents for pararenal aortic pathologies is safe and feasible with excellent patency and low incidence of endoleaks
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Konstantinos P. Donas, Giuseppe Panuccio, Giovanni Torsello, Martin Austermann, Dieter Mayer, Felice Pecoraro, Mario Lachat, Zoran Rancic, Donas KP, Pecoraro F, Torsello G, Lachat M, Austermann M, Mayer D, Panuccio G, Rancic Z, University of Zurich, and Donas, K P
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Male ,medicine.medical_specialty ,Time Factors ,Endoleak ,medicine.medical_treatment ,EVAR, aneurysm, chimney, periscopes ,Aortic Diseases ,610 Medicine & health ,Kaplan-Meier Estimate ,Revascularization ,Balloon ,Prosthesis Design ,Settore MED/22 - Chirurgia Vascolare ,Aortography ,Risk Assessment ,2705 Cardiology and Cardiovascular Medicine ,Blood Vessel Prosthesis Implantation ,Predictive Value of Tests ,Risk Factors ,Angioplasty ,Germany ,medicine ,Humans ,Vascular Patency ,Computed tomography angiography ,Aged ,Retrospective Studies ,Aged, 80 and over ,medicine.diagnostic_test ,business.industry ,Stent ,Perioperative ,medicine.disease ,10020 Clinic for Cardiac Surgery ,2746 Surgery ,Surgery ,Blood Vessel Prosthesis ,Stenosis ,Treatment Outcome ,Cuff ,Female ,Stents ,Radiology ,Cardiology and Cardiovascular Medicine ,business ,Tomography, X-Ray Computed ,Angioplasty, Balloon ,Switzerland - Abstract
Background To present the clinical experience of consecutive series with use of balloon-expandable and self-expanding chimney endografts (balloon-expandable covered stent group [BECS] vs self-expanding covered stent group [SECS]) in the endovascular treatment of challenging aortic pathologies requiring renal and/or visceral revascularization. Methods Between January 2009 and May 2011, data for 37 high-risk patients from one center and 35 patients from another institution, with pararenal aortic pathologies treated by the chimney endovascular technique, were prospectively collected. The chimney-graft technique is based on the deployment of a covered or bare-metal stent parallel to the aortic endograft, thereby creating a conduit that runs outside the aortic main endograft, and has been proposed to ensure secure proximal fixation extending the sealing zones. Results Forty-six consecutive target vessels (43 renal arteries and 3 superior mesenteric arteries) were revascularized by the Advanta (Atrium, Hudson, NH) BECS (1.2 chimneys/patient); in contrast, 81 consecutive target vessels (64 renal arteries, 11 superior mesenteric arteries, and 6 celiac trunks) were revascularized by the Viabahn (Gore, Flagstaff, Ariz) SECS (2.3 chimneys/patient). The success rate for target vessel preservation was 97.8% for the BECS group and 100% for the SECS group in the entire follow up. There was one symptomatic left renal artery occlusion of the BECS group treated by open thrombectomy of the left renal artery and placement of 8-mm Dacron (BBraun, Aesculap AG, Tuttlingen, Germany) iliorenal bypass. Additionally, one patient underwent repeat balloon angioplasty with a 5-mm balloon due to high-grade in-stent stenosis of a 6 × 59 Advanta stent graft 12 months postoperatively. Overall, one perioperative (and not present in the computed tomography angiography at discharge) type Ia endoleak was detected in the BECS group. In contrast, five perioperative type Ia endoleaks were present in the SECS group; however, only one of them was persistent in the radiological imaging and was treated by proximal extension of a 5-mm cuff, 1 year postoperatively, due to continuous aneurismal sac increase. No patient of any subgroup developed postoperative persistent renal insufficiency with need of hemodialysis. Thirty-day and during the follow-up procedure-related mortality was 0% for both BECS and SECS groups. Conclusions In summary, midterm results of use of covered chimney stents for pararenal aortic pathologies show safety and feasibility with excellent patency and low incidence of endoleaks.
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- 2011
24. Urgent endovascular repair of juxtarenal/pararenal aneurysm by off-the-shelf multibranched endograft.
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Gallitto E, Faggioli G, Austermann M, Kölbel T, Tsilimparis N, Dias N, Melissano G, Simonte G, Katsargyris A, Oikonomou K, Mani K, Pedro LM, Cecere F, Haulon S, and Gargiulo M
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- Humans, Male, Retrospective Studies, Aged, Female, Time Factors, Aged, 80 and over, Risk Factors, Europe, Treatment Outcome, Stents, Aortic Aneurysm, Thoracic surgery, Aortic Aneurysm, Thoracic mortality, Aortic Aneurysm, Thoracic diagnostic imaging, Risk Assessment, Endovascular Procedures instrumentation, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Prosthesis Design, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal mortality, Aortic Aneurysm, Abdominal diagnostic imaging, Hospital Mortality, Postoperative Complications etiology, Postoperative Complications mortality
- Abstract
Objective: To report outcomes of urgent juxtarenal/pararenal aneurysms (J/P-AAAs) managed by off-the-shelf multibranched thoracoabdominal endografts (Cook, T-branch)., Methods: In this observational, multicenter, retrospective study, patients with J/P-AAAs treated by urgent endovascular repair by T-branch in 23 European aortic centers, from 2013 to 2023, were analyzed. Contained J/P-AAAs rupture, presence of related symptoms, and aneurysm diameter of >70 mm were considered as indication for urgent repair. Technical success (TS), spinal cord ischemia (SCI), and 30-day/hospital mortality were assessed as early outcomes. Survival, freedom from reinterventions, and target artery instability (TAI) were evaluated during follow-up., Results: Overall, 197 patients (J-AAAs, n = 64 [33%]; P-AAAs, n = 95 [48%]; previous failed endovascular aneurysm repair (EVAR), n = 38 [19%]) were analyzed. The mean age and aneurysm diameter was 75 ± 8 years and 76 ± 4 mm, respectively. The American Society of Anesthesiologists score was 3 and 4 in 118 (60%) and 79 (40%) patients. Rupture, symptoms, and diameter of >70 mm were present in 51 (26%), 110 (56%), and 53 (27%) patients, respectively. An adjunctive proximal thoracic endograft was used in 28 cases (14%). The mean aortic coverage between the upper portion of the endograft and the lowest renal artery was 154 ± 49 mm. Single-stage repair and cerebrospinal fluid drainage were reported in 144 (73%) and 53 (27%) cases, respectively. TS was achieved in 182 (92%) cases (rupture, 84% vs no rupture, 95%; P = .02). Failures consist of TA loss (11 [6%]: renal artery, 9; celiac trunk, 2), type I to III endoleaks (2 [1%]), and 24-h mortality (2 [1%]). Rupture was a risk factor for technical failure (P = .02; odds ratio [OR], 3.8; 95% confidence interval [CI], 1.1-12.1). Overall, 15 patients (8%) had persistent SCI (rupture, 14% vs no rupture, 5%) with 11 (6%) , of paraplegia (rupture, 10% vs no rupture, 5%; P = .001). Rupture (P = .04; OR, 3.1; 95% CI, 1.1-8.9) and adjunctive proximal thoracic endograft (P = .01; OR, 4.1; 95% CI, 1.3-12.9) were risk-factors for SCI. Twenty-two patients (11%) died within 30 days or during a prolonged hospitalization. Previous failed EVAR (P = .04; OR, 3.6; 95% CI, 1.1-12.3), paraplegia (P < .001; OR, 9.9; 95% CI, 1.6-62.2) and postoperative mesenteric complications (P = .03; OR, 10.4; 95% CI, 1.2-93.3), as well as cardiac (P = .03; OR, 8.2; 95% CI, 2.0-33.0) and respiratory (P < .001; OR, 10.1; 95% CI, 2.9-35.2) morbidities were associated with 30-day/hospital mortality. The mean follow-up was 19 ± 5 months. The estimated 3-year survival and freedom from reinterventions was 58% and 77%, respectively. TAI occurred in 27 patients (14%) (occlusion, 15; endoleak, 14) with an estimated 3-year freedom from TAI of 72%., Conclusions: Urgent repair of J/P-AAAs by T-branch is feasible and effective with satisfactory TS and 30-day/hospital mortality in high-risk patients. However, extensive aortic coverage is necessary, leading to a non-negligible SCI rate, especially in case of aortic rupture or when adjunctive thoracic endografts are necessary. Previous failed EVAR and postoperative mesenteric complications, as well as cardiac and respiratory morbidities were associated with 30-day/hospital mortality and should be subjected to more research for the purposes of improving outcomes., Competing Interests: Disclosures E.G., G.F., M.A., N.T., G.M., G.S., A.K., K.O., K.M., L.M.P., and M.G. are proctors for Cook Medical and received travel, educational grants, or speaker's fees. T.K., N.D., and S.H. are consultants for Cook Medical and they have intellectual property with Cook Medical and received speaking fees, and research, travel, and educational grants., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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25. Correction: Machine learning detects symptomatic patients with carotid plaques based on 6-type calcium configuration classification on CT angiography.
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Pisu F, Chen H, Jiang B, Zhu G, Usai MV, Austermann M, Shehada Y, Johansson E, Suri J, Lanzino G, Benson JC, Nardi V, Lerman A, Wintermark M, and Saba L
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- 2024
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26. Machine learning detects symptomatic patients with carotid plaques based on 6-type calcium configuration classification on CT angiography.
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Pisu F, Chen H, Jiang B, Zhu G, Usai MV, Austermann M, Shehada Y, Johansson E, Suri J, Lanzino G, Benson JC, Nardi V, Lerman A, Wintermark M, and Saba L
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- Humans, Male, Female, Aged, Retrospective Studies, Middle Aged, Aged, 80 and over, Carotid Stenosis diagnostic imaging, Calcium metabolism, Carotid Artery Diseases diagnostic imaging, Machine Learning, Computed Tomography Angiography methods, Plaque, Atherosclerotic diagnostic imaging
- Abstract
Objectives: While the link between carotid plaque composition and cerebrovascular vascular (CVE) events is recognized, the role of calcium configuration remains unclear. This study aimed to develop and validate a CT angiography (CTA)-based machine learning (ML) model that uses carotid plaques 6-type calcium grading, and clinical parameters to identify CVE patients with bilateral plaques., Material and Methods: We conducted a multicenter, retrospective diagnostic study (March 2013-May 2020) approved by the institutional review board. We included adults (18 +) with bilateral carotid artery plaques, symptomatic patients having recently experienced a carotid territory ischemic event, and asymptomatic patients either after 3 months from symptom onset or with no such event. Four ML models (clinical factors, calcium configurations, and both with and without plaque grading [ML-All-G and ML-All-NG]) and logistic regression on all variables identified symptomatic patients. Internal validation assessed discrimination and calibration. External validation was also performed, and identified important variables and causes of misclassifications., Results: We included 790 patients (median age 72, IQR [61-80], 42% male, 64% symptomatic) for training and internal validation, and 159 patients (age 68 [63-76], 36% male, 39% symptomatic) for external testing. The ML-All-G model achieved an area-under-ROC curve of 0.71 (95% CI 0.58-0.78; p < .001) and sensitivity 80% (79-81). Performance was comparable on external testing. Calcified plaque, especially the positive rim sign on the right artery in older and hyperlipidemic patients, had a major impact on identifying symptomatic patients., Conclusion: The developed model can identify symptomatic patients using plaques calcium configuration data and clinical information with reasonable diagnostic accuracy., Clinical Relevance: The analysis of the type of calcium configuration in carotid plaques into 6 classes, combined with clinical variables, allows for an effective identification of symptomatic patients., Key Points: • While the association between carotid plaques composition and cerebrovascular events is recognized, the role of calcium configuration remains unclear. • Machine learning of 6-type plaque grading can identify symptomatic patients. Calcified plaques on the right artery, advanced age, and hyperlipidemia were the most important predictors. • Fast acquisition of CTA enables rapid grading of plaques upon the patient's arrival at the hospital, which streamlines the diagnosis of symptoms using ML., (© 2023. The Author(s), under exclusive licence to European Society of Radiology.)
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- 2024
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27. Intravascular Iliac Artery Lithotripsy to Facilitate Aortic Endograft Delivery: Midterm Results of a Dual-Center Experience.
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Fazzini S, Pennetta FF, Torsello G, Turriziani V, Vona S, Ascoli Marchetti A, Ippoliti A, Austermann M, and Bosiers MJ
- Abstract
Purpose: To assess the feasibility and safety of intravascular lithotripsy (IVL) for enabling transfemoral abdominal (EVAR), thoracic (TEVAR), and thoracoabdominal (BEVAR) endovascular aneurysm repair in patients with narrow and calcified iliac arteries., Materials and Methods: Consecutive patients treated with IVL for severe calcified and narrowed iliac access before EVAR, TEVAR, or BEVAR between November 2020 and June 2022 were retrospectively evaluated. All anatomical iliac characteristics were acquired by multi-planar reconstruction of preoperative computed tomography angiography (CTA). The hostility of the vascular accesses was classified based on Peripheral Arterial Calcium Scoring System (PACSS) and calcified access severity score (CASS), a new score considering both anatomical (calcium grade and length, minimum lumen diameter [MLD], and tortuosity index) and aortic stent-graft (SG/MLD index) parameters. Primary endpoint was technical success defined as successful aortic endograft delivery and deployment without iliac rupture. Freedom from complications and primary patency were additionally analyzed., Results: Twenty-eight iliac axes were treated with IVL (8 bilateral) in 20 patients (mean age 74.5±6.7 years) with a mean follow-up of 26.5±6.2 (range 17-36) months. Ten patients underwent EVAR: 3 TEVAR, and 7 BEVAR procedures. In 14 patients (70%), aneurysm disease was associated with symptomatic aorto-iliac occlusive disease (AIOD), with Rutherford class III to IV. The PACSS was grade IV in 89% of the cases and the CASS (mean 14±2) was grade III to IV in all cases. The stent-graft (SG) outer diameter (5.60±1.65 mm) was significantly larger by 50% than MLD (3.96±1.20 mm), with an SG/MLD index of 1.50±0.51 (p<0.001). Technical success was 100%. No dissection, rupture, or distal embolization occurred. One (3.4%) bail-out stenting was necessary as endoconduit after IVL treatment. One month CTA showed that postoperative luminal gain increased by 93% (p<0.001). An improvement of 2 Rutherford classes occurred in all AIOD patients with a primary patency of 100% at last follow-up., Conclusions: This study shows the safety and feasibility of IVL as a valuable option to treat narrow and calcified iliac arteries to facilitate endograft delivery. Further studies will be useful to confirm these results., Clinical Impact: In this article, the use of intravascular iliac artery lithotripsy to facilitate aortic endograft delivery is explored. The presence of iliac severe calcifications still represents a contraindication for aortic endovascular repair. Intravascular lithotripsy increases the feasibility and safety of endovascular aortic procedures, facilitating endograft delivery and reducing the risk of iliac rupture and/or dissections by improving vessel compliance and luminal gain. This novel vessel preparation could be an alternative to "paving and cracking" and/or iliac conduits. This study describes a new score to classify the severity of iliac calcifications, considering anatomical parameters and the profile of aortic endografts delivery system., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Stefano Fazzini and Michel Joseph Bosiers have a consulting agreement with Shockwave Medical.
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- 2024
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28. Endovascular Repair of One-hundred Urgent and Emergent free or Contained Thoraco-abdominal Aortic Aneurysms Ruptures. An International Multi-Center Trans-Atlantic experience.
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Spath P, Tsilimparis N, Gallitto E, Becker D, Vacirca A, Berekoven B, Panuccio G, Karelis A, Kahlberg A, Melissano G, Dias N, Kölbel T, Austermann M, Faggioli G, Oderich G, and Gargiulo M
- Abstract
Objective: To analyze the outcomes of urgent/emergent endovascular aortic repair of patients with free/contained ruptured thoracoabdominal aortic aneurysms (rTAAA)., Background: Endovascular repair of rTAAA has been scarcely described in emergent setting., Methods: An international multicenter retrospective observational study (ClinicalTrials.govID:NCT05956873) from January-2015 to January-2023 in 6 European and 1 United States Vascular Surgery Centers. Primary end-points were technical success, 30-day and/or in-hospital mortality and follow-up survival., Results: A total of 100 rTAAA patients were included (75 male; mean age 73 y). All patients (86 contained and 14 free ruptures) were symptomatic and treated within 24-hours from diagnosis: multi-branched off-the-shelf devices (Zenith t-branch,Cook Medical Inc.Bjaeverskov,Denmark) in 88 patients, physician-modified endografts in 8, patient-specific device or parallel grafts in two patients each. Primary technical success was achieved in 89 patients and 30-day and/or in-hospital mortality was 24%. Major adverse events (MAEs) occurred in 34% of patients (permanent dialysis and paraplegia in 4 and 8 patients, respectively). No statistical differences were detected in mortality rates between free and contained ruptured patients (43%vs.21%; P =0.075). Multivariate analysis revealed contained rupture favoring technical success (Odd-Ratio10.1;95%Confidence-Interval:3.0-33.6; P =<0.001). MAEs (OR9.4;95%C-I:2.8-30.5; P =<0.001) and pulmonary complications (OR11.3;95%CI:3.0-41.5; P =<0.001) were independent risk factors for 30-day and/or in-hospital mortality. Median follow-up time was 13 months (interquartile range 5-24); 1-year survival rate was 65%. Aneurysm diameter>80 mm (Hazard-Ratio:2.0;95%CI:1.0-30.5; P =0.037), technical failure (HR:2.6;95%CI:1.1-6.5; P =0.045) and pulmonary complications (HR:3.0;95%CI:1.2-7.9; P =0.021) were independent risk factors for follow-up mortality., Conclusion: Endovascular repair of rTAAA shows high technical success; the presence of free rupture alone appear not to correlate with early mortality. Effective prevention/management of post-operative complications is crucial for survival., (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.)
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- 2024
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29. Transatlantic multicenter study on the use of a modified preloaded delivery system for fenestrated endovascular aortic repair.
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Tsilimparis N, Gouveia E Melo R, Schanzer A, Sobocinski J, Austermann M, Chiesa R, Resch T, Gargiulo M, Timaran C, Maurel B, Adam D, Dias N, Oderich GS, Kölbel T, Gomez Palones F, Simonte G, Giudice R, Mesnard T, Loschi D, Leone N, Gallito E, Spath P, Porras Cólon J, Elboushi A, Wachtmeister M, Sonesson B, Tenorio E, Panuccio G, Isernia G, and Bertoglio L
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- Humans, Male, Aged, Female, Blood Vessel Prosthesis, Endovascular Aneurysm Repair, Retrospective Studies, Cohort Studies, Treatment Outcome, Time Factors, Prosthesis Design, Blood Vessel Prosthesis Implantation, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Endovascular Procedures, Aortic Aneurysm, Thoracoabdominal
- Abstract
Objective: Analyze the outcomes of endovascular complex abdominal and thoracoabdominal aortic aneurysm repair using the Cook fenestrated device with the modified preloaded delivery system (MPDS) with a biport handle and preloaded catheters., Methods: A multicenter retrospective single arm cohort study was performed, including all consecutive patients with complex abdominal aortic aneurysm repair and thoracoabdominal aortic aneurysms treated with the MPDS fenestrated device (Cook Medical). Patient clinical characteristics, anatomy, and indications for device use were collected. Outcomes, classified according to the Society for Vascular Surgery reporting standards, were collected at discharge, 30 days, 6 months, and annually thereafter., Results: Overall, 712 patients (median age, 73 years; interquartile range [IQR], 68-78 years; 83% male) from 16 centers in Europe and the United States treated electively were included: 35.4% (n = 252) presented with thoracoabdominal aortic aneurysms and 64.6% (n = 460) with complex abdominal aortic aneurysm repair. Overall, 2755 target vessels were included (mean ,3.9 per patient). Of these, 1628 were incorporated via ipsilateral preloads using the MPDS (1440 accessed from the biport handle and 188 from above). The mean size of the contralateral femoral sheath during target vessel catheterization was 15F ± 4, and in 41 patients (6.7%) the sheath size was ≤8F. Technical success was 96.1%. Median procedural time was 209 minutes (IQR, 161-270 minutes), contrast volume was 100 mL (IQR, 70-150mL), fluoroscopy time was 63.9 minutes (IQR, 49.7-80.4 minutes) and median cumulative air kerma radiation dose was 2630 mGy (IQR, 838-5251 mGy). Thirty-day mortality was 4.8% (n = 34). Access complications occurred in 6.8% (n = 48) and 30-day reintervention in 7% (n = 50; 18 branch related). Follow-up of >30 days was available for 628 patients (88%), with a median follow-up of 19 months (IQR, 8-39 months). Branch-related endoleaks (type Ic/IIIc) were observed in 15 patients (2.6%) and aneurysm growth of >5 mm was observed in 54 (9.5%). Freedom from reintervention at 12 and 24 months was 87.1% (standard error [SE],1.5%) and 79.2% (SE, 2.0%), respectively. Overall target vessel patency at 12 and 24 months was 98.6% (SE, 0.3%) and 96.8% (SE, 0.4%), respectively, and was 97.9% (SE, 0.4%) and 95.3% (SE, 0.8%) for arteries stented from below using the MPDS, respectively., Conclusions: The MPDS is safe and effective. Overall benefits include a decrease in contralateral sheath size in the treatment of complex anatomies with favorable results., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2023
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30. Experience with the Ankura Thoracic Stent Graft and In-situ Fenestration for the Left Subclavian Artery with the Fu-Through Needle - a Technical Overview and Comparison to Similar Endovascular Techniques.
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Usai MV and Austermann M
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- Humans, Aorta, Thoracic surgery, Blood Vessel Prosthesis, Retrospective Studies, Stents, Subclavian Artery surgery, Treatment Outcome, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Aortic Dissection, Blood Vessel Prosthesis Implantation methods, Endovascular Procedures
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Thoracic endovascular aortic repair (TEVAR) is a widespread minimally invasive procedure prevalently used to treat thoracic aortic pathologies. However, when the left subclavian artery (LSA) is involved in the pathology, a more complex surgical approach is required to guarantee the perfusion of the vertebral and brachial arteries. In fact, coverage of the LSA has been proven to be associated with a higher risk of stroke, spinal cord ischemia, and arm ischemia.Historically, carotid-subclavian bypass or subclavian transposition has been the only treatment options to restore the perfusion of the LSA. For the past 10 years, different endovascular techniques have been implemented in the endovascular armamentarium to reduce the risk of complications related to surgical treatment such as infection, bleeding, and chylothorax.Currently, physician-modified grafts, in situ fenestration, chimneys, and branched or fenestrated devices are available. The aim of this overview is to describe the technique with the Ankura thoracic stent graft and in situ fenestration with the Futhrough needle and thus to shed light on the different approaches by comparing their pros and cons., Competing Interests: Marco Virgilio Usai is consultant for Lifetech Company., (Thieme. All rights reserved.)
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- 2023
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31. Two-year target vessel-related outcomes following use of off-the-shelf branched endografts for the treatment of thoracoabdominal aortic aneurysms.
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Tsilimparis N, Bosiers M, Resch T, Torsello G, Austermann M, Rohlffs F, Coates B, Yeh C, and Kölbel T
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- Male, Humans, Middle Aged, Aged, Female, Blood Vessel Prosthesis adverse effects, Treatment Outcome, Risk Factors, Postoperative Complications, Stents adverse effects, Prosthesis Design, Aortic Aneurysm, Thoracoabdominal, Blood Vessel Prosthesis Implantation, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Aortic Aneurysm, Thoracic complications, Endovascular Procedures
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Objective: The aim of this study was to assess clinical outcomes and target vessel patency through 2 years following thoracoabdominal aortic aneurysms (TAAA) repair with the off-the-shelf Zenith t-Branch Thoracoabdominal Endovascular Graft (William Cook Europe)., Methods: This post-market observational study was conducted at three European sites with ambispective enrollment from 2012 to 2017. Patients underwent endovascular TAAA repair with the t-Branch graft and bridging stent grafts (BSGs) for the celiac (CA), superior mesenteric (SMA), left renal (LRA), and/or right renal (RRA) arteries. Follow-up was through 2 years, per sites' standard of care. Procedural and 1-year results were reported previously., Results: Eighty patients (mean age, 71.0±7.4 years; 70.0% men) were enrolled; six patients had symptomatic TAAAs, and 15 patients had contained ruptures. Technical success was achieved in 98.8% of patients (79/80). Median follow-up was 22.2 months (interquartile range, 9.2-25.1 months). At 24 months, Kaplan-Meier (KM) freedom from all-cause and aneurysm-related mortality were 78.5% and 98.6%, respectively. Beyond 12 months, 38 adverse events occurred in 20 patients, including two aortic ruptures (one study aneurysm and one non-study aneurysm) and six deaths (none aneurysm-related, as reported by the site). Compared with postprocedure, maximum aneurysm diameter decreased (>5 mm) in 84.6% (44/52), remained unchanged in 3.8% (2/52), and increased (>5 mm) in 11.5% (6/52) of patients with imaging follow-up after 12 months. No conversions to open repair, and no t-Branch graft or other endograft component migration or integrity issues were reported. No loss of patency was reported in the t-Branch or iliac limb grafts throughout the study. Throughout study duration, four patients had five imaging-reported BSG compressions, none of which required secondary intervention. KM freedom from secondary intervention was 76.3% at 24 months. Fourteen target vessel-related secondary interventions were performed, primarily consisting of stent placement for endoleak, stenosis, or occlusion. KM freedom from loss of primary patency was 94.8%, 100%, 91.3%, and 89.3% for the CA, SMA, LRA, and RRA, respectively, at 24 months. KM freedom from loss of secondary patency in the CA, SMA, LRA, and RRA were 96.3%, 100%, 98.2%, and 98.3% at 24 months, respectively. A total of 298 vessels were targeted, of which 12 were occluded over the study period., Conclusions: Primary and secondary target vessel patency rates through 2 years demonstrated durable repair with the t-Branch graft in patients treated for symptomatic or asymptomatic thoracoabdominal aortic aneurysms., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2023
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32. The optimal operative protocol to accomplish CO 2 -EVAR resulting from a prospective interventional multicenter study.
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Vacirca A, Faggioli G, Vaccarino R, Dias N, Austermann M, Usai MV, Oberhuber A, Schäfers JF, Bisdas T, Patelis N, Palermo S, and Gargiulo M
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- Humans, Male, Aged, Female, Aortography methods, Carbon Dioxide adverse effects, Prospective Studies, Contrast Media adverse effects, Treatment Outcome, Retrospective Studies, Multicenter Studies as Topic, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Abdominal complications
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Objectives: Carbon dioxide (CO
2 ) angiography for endovascular aortic repair (CO2 -EVAR) is used to treat abdominal aortic aneurysms (AAAs), especially in patients with chronic kidney disease or allergy to iodinated contrast medium (ICM). However, some technical issues regarding the visualization of the lowest renal artery (LoRA) and the best quality image through angiographies performed from pigtail or introducer sheath are still unsolved. The aim of this study was to analyze different steps of CO2 -EVAR to create an operative standardized protocol., Methods: Patients undergoing CO2 -EVAR were prospectively enrolled in five European centers from 2019 to 2021. CO2 -EVAR was performed using an automated injector (pressure, 600 mmHg; volume, 100 cc); a small amount of ICM was injected in case of difficulty in LoRA visualization. LoRA visualization and image quality (1 = low, 2 = sufficient, 3 = good, 4 = excellent) were analyzed at different procedure steps: preoperative CO2 angiography from pigtail and femoral introducer sheath (first step), angiographies from pigtail at 0%, 50%, and 100% of proximal main body deployment (second step), contralateral hypogastric artery (CHA) visualization with CO2 injection from femoral introducer sheath (third step), and completion angiogram from pigtail and femoral introducer sheath (fourth step). Intraoperative and postoperative CO2 -related adverse events were also evaluated. χ2 and Wilcoxon tests were used for statistical analysis., Results: In the considered period, 65 patients undergoing CO2 -EVAR were enrolled (55/65 [84.5%] male; median age, 75 years [interquartile range (IQR), 11.5 years]). The median ICM injected was 17 cc (IQR, 51 cc); 19 (29.2%) of 65 procedures were performed with 0 cc ICM. Fifty-five (84.2%) of 65 patients underwent general anesthesia. In the first step, median image quality was significantly higher with CO2 injected from femoral introducer (pigtail, 2 [IQR, 3] vs introducer, 3 [IQR, 3]; P = .008). In the second step, LoRA was more frequently detected at 50% (93% vs 73.2%; P = .002) and 100% (94.1% vs 78.4%; P = .01) of proximal main body deployment compared with first angiography from pigtail; similarly, image quality was significantly higher at 50% (3 [IQR, 3] vs 2 [IQR, 3]; P ≤ .001) and 100% (4 [IQR, 3] vs 2 [IQR, 3]; P = .001) of proximal main body deployment. CHA was detected in 93% cases (third step). The mean image quality was significantly higher when final angiogram (fourth step) was performed from introducer (pigtail, 2.6 ± 1.1 vs introducer, 3.1 ± 0.9; P ≤ .001). The intraoperative (7.7%) and postoperative (12.5%) adverse events (pain, vomiting, diarrhea) were all transient and clinically mild., Conclusions: Preimplant CO2 angiography should be performed from femoral introducer sheath. Gas flow impediment created by proximal main body deployment can improve image quality and LoRA visualization with CO2 . CHA can be satisfactorily visualized with CO2 alone. Completion CO2 angiogram should be performed from femoral introducer sheath. This operative protocol allows performance of CO2 -EVAR with 0 cc or minimal ICM, with a low rate of mild temporary complications., (Copyright © 2023 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)- Published
- 2023
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33. Aortic endograft and bridging stent-graft remodeling after branched endovascular aortic repair.
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Fazzini S, Torsello G, Austermann M, Beropoulis E, Munaò R, and Torsello GF
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- Aged, Aorta diagnostic imaging, Aorta physiopathology, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Databases, Factual, Endovascular Procedures adverse effects, Female, Foreign-Body Migration etiology, Humans, Male, Middle Aged, Prosthesis Design, Prosthesis Failure, Retrospective Studies, Time Factors, Treatment Outcome, Aorta surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents, Vascular Remodeling
- Abstract
Objectives: The results of branched endovascular repair of thoracoabdominal aneurysms are mainly dependent on durability of the graft used. The purpose of this study was to evaluate postoperative aortic main body and bridging stent-graft remodeling, and their impact on bridging stent-graft instability at one year., Methods: Computed tomoangiographies of 43 patients (43 aortic main body mated with 171 bridging stent-grafts) were analyzed before and after branched endovascular repair as well as after a follow-up of 12 months. Primary endpoint was aortic main body remodeling (migration >5 mm, shortening >5 mm, scoliosis >5° or lordosis >5°). Shortening was defined as a reduced length in the long axis, scoliosis as left-right curvature, and lordosis as antero-posterior curvature. Aortic main body remodeling, aneurysm sac changes, and bridging stent-graft tortuosity were evaluated to study their correlations and the impact on the bridging stent-graft instability., Results: At 12 months, aortic main body remodeling was observed in 72% of the cases, migration in 39.5% (mean 5.21 mm), shortening in 41.9% (mean 5.79 mm), scoliosis in 58.1%, (mean 10.10°), lordosis in 44.2% (mean 5.78°). Migration, shortening, and scoliosis were more frequent in patients with larger aneurysms ( p = .005), while scoliosis was significantly more frequent in type II thoracoabdominal aneurysm ( p = .019). Aortic main body remodeling was significantly associated to bridging stent-graft remodeling (r: 0.3-0.48). The bridging stent-graft instability rate was 9.3%. Despite a trend toward significance ( p = .07), none of the evaluated aortic main body and bridging stent-graft changes were associated with bridging stent-graft instability at 12 months., Conclusions: Aortic main body remodeling is frequent especially in large and extended thoracoabdominal aneurysm aneurysms. Aortic main body and bridging stent-graft remodeling was significantly correlated. While these geometric changes had no significant impact on bridging stent-graft instability at one year, a close long-term follow-up after branched endovascular repair could predict bridging stent-graft failures.
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- 2021
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34. Early and midterm results from a postmarket observational study of Zenith t-Branch thoracoabdominal endovascular graft.
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Bosiers M, Kölbel T, Resch T, Tsilimparis N, Torsello G, and Austermann M
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- Aged, Aortic Dissection diagnostic imaging, Aortic Dissection mortality, Aortic Dissection physiopathology, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Aortic Aneurysm, Thoracic physiopathology, Aortic Rupture diagnostic imaging, Aortic Rupture mortality, Aortic Rupture physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endoleak etiology, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Germany, Humans, Male, Middle Aged, Product Surveillance, Postmarketing, Prospective Studies, Prosthesis Design, Prosthesis Failure, Retrospective Studies, Risk Assessment, Risk Factors, Sweden, Time Factors, Treatment Outcome, Vascular Patency, Aortic Dissection surgery, Aortic Aneurysm, Thoracic surgery, Aortic Rupture surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Objective: We have reported the short-term outcomes regarding the safety of the off-the-shelf Zenith t-Branch multibranched thoracoabdominal stent-graft (William Cook Europe ApS, Bjaeverskov, Denmark) in a postmarket, multicenter study., Methods: Patients who had been treated with the t-Branch device from September 2012 to November 2017 at three European centers were either prospectively or retrospectively enrolled in the present study. Device implantation and postprocedural follow-up were performed according to the standard of care at each center. The primary objectives of the present study were to assess the procedure-related mortality and morbidity at 30 days and 1 year and to assess the presence of endoleaks, device integrity, and stent-graft and branch vessel patency., Results: A total of 80 patients were included in the present study (mean age, 71.0 ± 7.4 years; 70.0% male). Most (n = 77) had been treated for thoracoabdominal aortic aneurysms (TAAAs) and the rest for dissection (n = 3). Most TAAAs were stable (72.7%; 56 of 77). The remaining TAAAs were symptomatic (7.8%; 6 of 77) or had a contained rupture (19.5%; 15 of 77). The t-Branch device was successfully deployed in 79 patients. In one patient, the delivery system of the device could not be advanced through the iliac artery. Within 30 days, one patient had died (1.3%). At 1 year, seven patients had died (8.8%), and no aortic rupture or conversion to open surgery had been reported. The 30-day neurologic events included stroke in three patients (3.8%), paraplegia in one (1.3%), and paraparesis in six patients (7.5%). Secondary interventions were required in nine patients (11.3%) during follow-up. Postoperative endoleaks were observed in 37 of 72 patients (51.4%), including type II endoleak in 30, type Ia in 4, and type III endoleak in 6 patients. At 1 year, endoleaks had been reported in 20 patients (16 with type II and 4 with type III). The t-Branch main body graft patency was 100% throughout the 1-year follow-up period. At 30 days after the procedure, all celiac and superior mesenteric artery branches were patent and one left renal and one right renal branch were occluded. At 1 year, occlusion had developed in three bridging stent-grafts for the celiac artery, one for the left renal artery, and two for the right renal artery., Conclusions: The t-Branch device appears safe, with good 30-day and 1-year mortality and morbidity in the present study, including both stable and symptomatic cases., (Copyright © 2021 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2021
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35. The role of surgical and total endovascular techniques in the treatment of ruptured juxtarenal aortic aneurysms.
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Keschenau PR, Beropoulis E, Gombert A, Jacobs MJ, Torsello G, Austermann M, Kotelis D, and Donas KP
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- Aged, Aorta, Abdominal, Humans, Male, Postoperative Complications, Retrospective Studies, Risk Factors, Treatment Outcome, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
- Abstract
Background: Ruptured juxtarenal aortic aneurysms (RJAAA) represent a special challenge in clinical practice, but the evidence to guide therapeutic decision-making is scarce. The aim of this study was to present two different approaches, open surgical (OAR) and chimney endovascular repair (CHEVAR), for treating patients with RJAAA. Patients and methods: This retrospective two-center study included all patients per center undergoing OAR or CHEVAR for RJAAA between February 2008 and January 2020. Juxtarenal aortic aneurysms were defined as having an infrarenal neck of 2-5 mm, measured after three-dimensional reconstruction of the computed tomography angiography scan. Results: 12 OAR patients (10 male, median age 73 years [58-90 years]) and 6 CHEVAR patients (all male, median age 74 years [59-83 years]) were included. In the OAR group, the proximal aortic clamping was suprarenal in 7 and interrenal in 5 patients. Cold renal perfusion was used in 4 patients, in 2 with suprarenal aortic clamping and in 2 with interrenal aortic clamping. 3 CHEVAR patients received a single renal chimney, the other 3 received double renal chimneys. Technical success was 12/12 in the OAR group 5/6 in the CHEVAR group. In-hospital mortality and 30-day mortality were 3/12 after OAR and 0/6 after CHEVAR. 2 OAR patients required transient dialysis. Median in-hospital stay was 14 (10-63) and 8 (6-21) days and median follow-up (FU) was 20 (3-37) and 30 (7-101) months, respectively. No further deaths occurred during FU. One OAR patient and 4 CHEVAR patients required aortic reinterventions. Conclusions: RJAAAs are rare. Both OAR and CHEVAR can represent adequate treatments for RJAAAs. OAR is the traditional approach, but CHEVAR has - in a high-volume center - promising early results with nonetheless a need for continuous FU to prevent reinterventions. Defining the studied aortic pathology precisely is essential for future research in order to draw valid conclusions.
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- 2021
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36. Performance of the Gore VBX Balloon Expandable Endoprosthesis as Bridging Stent-Graft in Branched Endovascular Aortic Repair for Thoracoabdominal Aneurysms.
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Torsello GB, Pitoulias A, Litterscheid S, Berekoven B, Torsello GF, Austermann M, and Bosiers MJ
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- Blood Vessel Prosthesis, Humans, Prosthesis Design, Retrospective Studies, Stents, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects
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Purpose: Bridging stent stability is crucial for efficacy and safety of branched aortic endovascular repair (bEVAR) of thoracoabdominal aortic aneurysms (TAAAs). In this study, we assess the performance of the new Viabahn Balloon-Expandable endoprosthesis (VBX) in bEVAR. Based on our learning curve we give recommendations for a safe and effective use of the device., Materials and Methods: We prospectively collected the data of patients with TAAAs undergoing bEVAR between December 2017 and December 2019. All patients with implantation of at least 1 VBX stent-graft as bridging stent were included in our single-center analysis. Demographic, comorbidity, and computed tomography angiography (CTA) data of 112 patients were retrospectively evaluated. Primary endpoint was a composite of branch-related technical success and freedom from target vessel instability. Secondary endpoints were clinical and ongoing clinical success., Results: Primary endpoint: technical success was achieved in all patients (100%) with a freedom from target vessel instability of 96.3% after a median follow-up of 18 months. Overall mortality was 13.4% (n=15) and 13 patients underwent secondary interventions, 12 of them are still alive and 1 suffered from aneurysm sac expansion, consequently an ongoing clinical success of 75.9% was reached. After modification of the implantation technique during the course of the study by selecting longer stent lengths after accurate estimation of vessel curvature and expected adaptation of the flexible endoskeleton to the specific anatomical conditions, no type Ic endoleaks were observed in the last 70 cases., Conclusions: The VBX stent-graft can be safely used as bridging stent for branched thoracoabdominal repair. However, learning curve should be considered to avoid type Ic endoleak and edge stenosis. Based on this experience longer landing zones and 2-step deployment of VBX are useful for successful bridging also of challenging target vessels.
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- 2021
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37. Preliminary Clinical and Radiologic Outcome of Matched Patients with Thoracoabdominal Aortic Aneurysms Treated by Low-Profile vs Standard Profile Branched Aortic Endografts.
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Puta B, Fazzini S, Torsello G, Pipitone MD, Austermann M, Beropoulis E, and Torsello GF
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- Aged, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Postoperative Complications diagnostic imaging, Predictive Value of Tests, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Aortic Aneurysm, Thoracic surgery, Aortography, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Computed Tomography Angiography, Endovascular Procedures instrumentation, Stents
- Abstract
Background: Durability of low-profile branched aortic stent-grafts (LPSG) in the treatment of patients with thoracoabdominal aortic aneurysms (TAAA) remains unclear. Objective of this study is to compare the outcomes of LPSG with standard profile branched aortic stent-grafts (SPSG)., Methods: Between January 2016 and January 2020, 225 consecutive patients with TAAA were treated by branched endovascular aortic repair (BEVAR). Twenty-four patients who were treated with a LPSG were compared to 24 patients who received SPSG as a control group. Control patients were selected according to aneurysm size (maximum aneurysm diameter) and extension (Crawford classification) as well as availability of adequate preoperative and postoperative CT-angiograms at 24 months. The primary endpoint was ongoing clinical success defined as successful implantation and freedom from aneurysm- or procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion or rupture and conversion. Secondary endpoints were radiological changes of the branched endograft (migration, shortening, scoliosis, lordosis, and fracture)., Results: After a median follow-up of 22.6 (LPSG) and 26.2 months (SPSG), no significant difference was found in terms of technical success (100% in both groups), late mortality (4.2% vs 0%), aneurysm diameter increase (4.2% in both groups) and reinterventions (25% vs 37.5%). Infection, thrombosis, aneurysm expansion or rupture and conversion were not observed. Radiological analysis of aortic graft remodeling showed no fracture and no significant migration, shortening, scoliosis and lordosis of the LPSG (6.1 mm, 7.5 mm, 12.8° and 6.1°) compared to SPSG (3.9 mm, 5.1 mm, 7.9° and 5.6°) after 2 years., Conclusion: The clinical and radiological findings of the present study showed no increased mortality and complications for the matched patients who underwent treatment with low-profile vs standard-profile BEVAR. This study provides preliminary evidence of safety and efficacy of low-profile branched endografts in patients with demanding iliac access vessels., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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38. Fatigue Resistance of the Advanta V12/iCast and Viabahn Balloon-Expandable Stent-Graft as Bridging Stents in Experimental Fenestrated Endografting.
- Author
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Torsello G, Müller M, Litterscheid S, Berekoven B, Austermann M, and Torsello GF
- Subjects
- Humans, Prosthesis Design, Stents, Treatment Outcome, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation adverse effects
- Abstract
Purpose: Bridging stents undergo millions of cycles during respiratory movements of the kidneys throughout the patient's life. Thus, understanding the response of fabric and endoskeleton of the stent to cyclic loading over the time is crucial. In this study, we compare the fatigue resistance of the Viabahn Balloon-Expandable stent-graft (VBX) with the widely used Advanta V12/iCast under prolonged stress induction., Materials and Methods: A polyester test sheet with 10 fenestrations was used simulating a fenestrated endograft. Five 6×59 mm VBX stent-grafts and five 6×58 mm Advanta stent-grafts were implanted into 6×6 mm fenestrations. The stents were flared with a 10×20 mm PTA (percutaneous transluminal angioplasty) catheter and connected with a fatigue stress machine. All stent-grafts were evaluated by microscopy and radiography at baseline and after regular intervals until 50,000,000 cycles were applied, simulating a life span of approximately 75 months. Freedom from fracture (FF), freedom from initial polytertafluoroethylene (PTFE) changes (FIC), and from PTFE breakpoint (FBP, all-layer defect) were calculated., Results: Digital radiographic images did not show any stent fracture in both groups after 50,000,000 cycles. The VBX stent-graft was free from any all-layer defects at the conclusion of 50,000,00 cycles resulting in a significant higher FBP compared with Advanta V12 (50,000,000 vs 33,400,000; p<0.01). All-layer defects were observed only in the Advanta group. Two of 5 Advanta stents showed early penetration of the nitinol ring causing a defect of PTFE. Regarding FIC, there was no significant difference between the stents (3,400,000 in VBX vs 3,200,000 in Advanta)., Conclusions: In fatigue tests simulating respiration movements, VBX and Advanta V12 performed equally well in terms of fracture resistance and freedom from initial PTFE changes. VBX maintained freedom from PTFE breakpoint throughout the full 50,000,000 cycles. All-layers defects were detected only in Advanta and were mainly caused by penetration of the nitinol ring through the PTFE.
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- 2021
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39. The PROTAGORAS 2.0 Study to Identify Sizing and Planning Predictors for Optimal Outcomes in Abdominal Chimney Endovascular Procedures.
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Fazzini S, Martinelli O, Torsello G, Austermann M, Pipitone MD, Torsello GF, Irace L, and Donas KP
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- Aged, Aged, 80 and over, Aorta, Abdominal diagnostic imaging, Aorta, Abdominal physiopathology, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal physiopathology, Aortography, Blood Vessel Prosthesis Implantation adverse effects, Computed Tomography Angiography, Databases, Factual, Endoleak etiology, Endoleak prevention & control, Endovascular Procedures adverse effects, Female, Graft Occlusion, Vascular etiology, Graft Occlusion, Vascular prevention & control, Humans, Male, Prosthesis Design, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Vascular Patency, Aorta, Abdominal surgery, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Objective: The aim was to identify predictors of adequate pre-operative sizing and planning for chimney endovascular aortic repair (ChEVAR) in order to reduce the incidence of persistent type Ia endoleaks (IaELs) without influencing chimney graft (CG) patency., Methods: Consecutive patients who underwent ChEVAR between January 2009 and December 2017 at a single centre were evaluated retrospectively. Included were patients treated with one device combination (Medtronic Endurant mated with Getinge Advanta V12/iCast) and placement of single or double CG. The freedom from IaEL related re-interventions and primary CG patency was estimated by measuring aortic stent graft oversizing (OS), total neck length (TNL), and a composite parameter (L-OS: TNL [mm] + OS [%])., Results: Seventy-three patients who underwent placement of 101 CGs (45 single, 28 double) met the inclusion criteria. The median radiological follow up was 25.5 (interquartile range [IQR] 12-48) months. Freedom from IaEL related re-intervention was achieved in 94.6% with a median OS of 38.5% (IQR 30%-44%, p = .004), TNL 19 mm (16-25 mm, p = .62), and L-OS 59 (51-65, p = .018). Primary CG patency was achieved in 95% of the cases with a median OS of 36% (29%-42%, p = .008), TNL 19 mm (15.5-26 mm, p = .91), and L-OS 57 (50-64, p = .005). By using the receiver operating characteristic curve, an optimal cut off to prevent IaEL related re-interventions was identified by an OS of 30% (p < .001; L-OS 55, p = .006) and to avoid CG stenosis/occlusions by OS 42% (p < .001; L-OS 65, p < .001). In multivariable analysis, aortic endograft OS was the only independent parameter preventive for IaEL related re-intervention (odds ratio, 0.78; 95% confidence interval, 0.61-0.99)., Conclusion: With the Endurant-Advanta V12/iCast combination, an aortic stent graft OS of at least 30% (range 30%-42%) should be used to avoid type Ia endoleaks and likewise to ensure CG patency., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)
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- 2021
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40. Long-term Results of Thoracic Endovascular Aortic Repair Using a Low-Profile Stent-Graft.
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Beropoulis E, Fazzini S, Austermann M, Torsello GB, Damerau S, and Torsello GF
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- Aged, Aged, 80 and over, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Female, Humans, Male, Middle Aged, Prosthesis Design, Retrospective Studies, Treatment Outcome, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Stents
- Abstract
Purpose: To evaluate the long-term results associated with the Zenith Alpha thoracic stent-graft, which was designed to address challenging access vessel anatomy., Materials and Methods: A retrospective analysis was conducted of 44 consecutive patients (mean age 72.5±8.3 years; 25 men) treated in a single center between August 2010 and October 2014 with a minimum follow-up of 5 years in survivors. The Zenith Alpha thoracic stent-graft was used to treat thoracic aortic aneurysms (n=37), thoracoabdominal aortic aneurysm (n=5), or penetrating aortic ulcer (n=2). Ten patients (23%) were American Society of Anesthesiologists class IV, and 9 (20%) had nonelective procedures. Access vessel anatomy was demanding (mean minimum diameter 5.4 mm, tortuosity index 1.3). The primary endpoint at 5 years was ongoing clinical success (freedom from aneurysm-/procedure-related death, secondary intervention, type I or III endoleak, infection, thrombosis, aneurysm expansion, rupture, or conversion). Secondary endpoints were freedom from all-cause mortality, device migration, stent fractures, fabric erosions, endoleaks, neurological events, and access vessel complications., Results: The ongoing clinical success was 84% (37 of 44 patients) owing to 4 aneurysm-related deaths (9%), 3 type I or III endoleaks (1 in a deceased patient), and 1 aneurysm expansion without detectable endoleak. There were 3 access vessel complications (7%), and no postoperative neurological events. Migration was observed in 2 cases (5%). There were no stent fractures or fabric tears., Conclusion: Despite the alterations in stent-graft design and material to reduce profile, the Zenith Alpha thoracic stent-graft showed favorable long-term results even in multimorbid patients with demanding iliac anatomy.
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- 2021
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41. Outcomes of elective use of the chimney endovascular technique in pararenal aortic pathologic processes.
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Pitoulias GA, Torsello G, Austermann M, Pitoulias AG, Pipitone MD, Fazzini S, and Donas KP
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- Aged, Aged, 80 and over, Aorta, Abdominal diagnostic imaging, Aorta, Abdominal pathology, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal pathology, Blood Vessel Prosthesis, Comorbidity, Elective Surgical Procedures, Female, Humans, Male, Postoperative Complications etiology, Postoperative Complications therapy, Retrospective Studies, Risk Assessment, Risk Factors, Stents, Time Factors, Treatment Outcome, Vascular Patency, Aorta, Abdominal surgery, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation
- Abstract
Objective: In the treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes, chimney endovascular aneurysm repair (CHEVAR) represents an alternative technique for urgent cases. The aim of the study was to evaluate the outcomes of CHEVAR in the elective setting., Methods: We performed a retrospective analysis of prospectively collected records of 165 consecutive asymptomatic CHEVAR patients who were treated between March 2009 and January 2018 with the Endurant stent graft (Medtronic, Santa Rosa, Calif). A total of 244 chimney grafts (CGs) were implanted. The primary end point was clinical success, defined as freedom from procedure-related mortality, persistent type IA endoleak, occlusion or high-grade stenosis (>70%) of CGs, and any chimney technique-related secondary procedure for the entire follow-up period. Secondary clinical success included patients with successful treatment of a primary end point with a secondary endovascular procedure., Results: All 244 targeted chimney vessels were successfully cannulated. Total perioperative morbidity was 7.8% (n = 13), including 3 (1.8%) cases of bowel ischemia, 1 (0.6%) patient with renal ischemia, and 1 patient (0.6%) with stroke. Median follow-up was 25.5 ± 2.2 months. Both 30-day and follow-up procedure-related mortality rates were 1.8% (n = 3). Primary and secondary freedom from persistent type IA endoleak rates were 96.4% (n = 159) and 99.4% (n = 164), respectively. Primary and secondary CG patency rates were 92.2% (n = 225) and 95.9% (n = 234), respectively. The rate of reinterventions related to the chimney technique was 10.9% (n = 18), and 83.3% of them were performed by endovascular means. The estimated cumulative primary patency and freedom from persistent type IA endoleak were 87.5% and 95.3%, respectively, and the primary and secondary clinical successes rates at midterm were 80.3% and 87.5%, respectively., Conclusions: The elective use of CHEVAR with the Endurant stent graft in our series showed favorable midterm clinical results, which are similar to the published results of other total endovascular modalities. A prospective randomized trial of elective treatment of pararenal abdominal aortic aneurysms and aortic pathologic processes with current endovascular options is needed to assess the value of CHEVAR in the elective setting., (Copyright © 2020 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
- Published
- 2021
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42. Use of Stainless-Steel, Balloon-Expandable Chimney Grafts Is Durable Though Caution Is Required When Lining Angulated Renal Arteries.
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Taneva GT, Fazzini S, Pipitone MD, Karaolanis G, Torsello G, Bremer C, Austermann M, and Donas KP
- Subjects
- Aged, Aged, 80 and over, Alloys, Blood Vessel Prosthesis, Female, Humans, Male, Prosthesis Design, Retrospective Studies, Risk Factors, Stainless Steel, Treatment Outcome, Aneurysm diagnostic imaging, Aneurysm surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Renal Artery diagnostic imaging, Renal Artery surgery, Stents
- Abstract
Purpose: To analyze the overall performance of flexible nitinol stents used to line chimney grafts (CGs) during chimney endovascular aneurysm repair (chEVAR) of pararenal pathologies., Materials and Methods: A retrospective review was conducted of all 116 elective patients (mean age 74.3±7.2 years; 103 men) who underwent chEVAR with balloon-expandable Advanta V12/iCAST CGs in combination with the Endurant stent-graft between January 2009 and December 2017 at a single center. CG lining with a nitinol stent was electively performed in 43 target vessels of 32 patients. The Kaplan-Meier method was used to estimate the primary outcomes of CG patency and freedom from reintervention (FFR) at the patient level and according to the use of a stent to line the CG. Estimates are reported with the 95% confidence interval (CI). Adjusted odds ratios (ORs) were calculated to identify any confounding effect between the presence/absence of a stent lining or according to the number of CGs., Results: The mean radiological follow-up was 27.3 months (range 22.1-32.6). During this time, 8 CGs (4.7%) became occluded, 6 of them were lined with stents. Restoration of patency was possible in 3 of the 4 occluded stents that were associated with symptoms. First-year primary patency estimates were 96.9% (95% CI 92.5% to 100%) for the unlined group vs 77.1% (95% CI 58% to 95.3%; p=0.001) for the lined group, while FFR was 87.6% (95% CI 79.9% to 95.2%) vs 83.4% (95% CI 68.1% to 98.6%; p=0.82), respectively. Lining represented an independent risk factor for CG occlusion (OR 9.9, p=0.006)., Conclusion: CG lining performed mainly in angulated renal arteries during chEVAR was significantly associated with CG occlusion. These findings highlight the importance of not having the distal part of the CG impinge on the angulated segment of the target vessel.
- Published
- 2020
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43. Iliac Branch Devices With Standard vs Fenestrated/Branched Stent-Grafts: Does Aneurysm Complexity Produce Worse Outcomes? Insights From the pELVIS Registry.
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Spanos K, Kölbel T, Scheerbaum M, Donas KP, Austermann M, Rohlffs F, Verzini F, and Tsilimparis N
- Subjects
- Aged, Aged, 80 and over, Blood Vessel Prosthesis, Female, Humans, Male, Middle Aged, Pelvis, Prosthesis Design, Registries, Retrospective Studies, Risk Factors, Treatment Outcome, Aneurysm diagnostic imaging, Aneurysm surgery, Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Stents
- Abstract
Purpose: To compare the outcomes of iliac branch devices (IBD) used in combination with standard endovascular aneurysm repair (EVAR) vs with fenestrated/branched EVAR (f/bEVAR) to treat complex aortoiliac aneurysms. Materials and Methods: The pELVIS Registry database containing the outcomes of IBD use at 8 European centers was interrogated to identify all IBD procedures that were combined with either standard EVAR or f/bEVAR. Among 669 patients extracted from the database, 629 (mean age 72.1±8.8 years; 597 men) had received an IBD combined with standard EVAR vs 40 (mean age 71.1±8.0 years; 40 men) who underwent f/bEVAR with an IBD. The mean aortic aneurysm diameters were 46.4±13.3 mm in the f/bEVAR patients vs 45.0±15.5 mm in the standard EVAR cases. The groups were similar in terms of baseline clinical characteristics and aneurysm morphology. The Kaplan-Meier method was used to compare patient survival, IBD occlusion, type III endoleak, and aneurysm-related reinterventions in follow-up. The estimates are presented with the 95% confidence interval (CI). Results: Technical success was 100% in the f/bEVAR+IBD group and 99% in the EVAR+IBD group (p=0.85). The 30-day mortality was 0% vs 0.5%, respectively (p=0.66), while the 30-day reintervention rates were 7.5% vs 4.1% (p=0.31). The mean follow-up was 32.1±21.3 months for f/bEVAR+IBD patients (n=30) and 35.5±26.8 months for EVAR+IBD patients (n=571; p=0.41). The 12-month survival estimates were 93.4% (95% CI 93.2% to 93.6%) in the EVAR+IBD group vs 93.6% (95% CI 93.3% to 93.9%) for the f/bEVAR+IBD group (p=0.93). There were no occlusions or type III endoleaks in the f/bEVAR+IBD group at 12 months, while the estimates for freedom from occlusion and from type III endoleak in the EVAR+IBD group were 97% (95% CI 96.8% to 97.2%) and 98.5% (95% CI 98.4% to 98.6%), respectively. The 12-month estimates for freedom for aneurysm-related reintervention were 93% (95% CI 92.7% to 93.3%) in the EVAR+IBD group vs 86.4% (95% CI 85.9% to 86.9%) in the f/bEVAR+IBD patients (p=0.046). Conclusion: Treatment of complex aortoiliac disease with f/bEVAR+IBD can achieve equally good early and 1-year outcomes compared to treatment with IBDs and standard bifurcated stent-grafts, except for a somewhat higher reintervention rate in f/bEVAR patients.
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- 2020
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44. Stent-grafts are the best way to treat complex in-stent restenosis lesions in the superficial femoral artery: 24-month results from a multicenter randomized trial.
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Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroë H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, and Wauters J
- Subjects
- Aged, Aged, 80 and over, Angioplasty, Balloon adverse effects, Belgium, Blood Vessel Prosthesis Implantation adverse effects, Constriction, Pathologic, Female, Femoral Artery diagnostic imaging, Femoral Artery physiopathology, Germany, Humans, Male, Middle Aged, Peripheral Arterial Disease diagnostic imaging, Peripheral Arterial Disease physiopathology, Prospective Studies, Recurrence, Time Factors, Treatment Outcome, Vascular Patency, Angioplasty, Balloon instrumentation, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Femoral Artery surgery, Peripheral Arterial Disease therapy, Stents
- Abstract
Background: This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE
® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure., Methods: A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit., Results: In the VIABAHN® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001)., Conclusions: The treatment of femoropopliteal in-stent restenosis with a VIABAHN® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.- Published
- 2020
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45. Outcomes of bridging stent grafts in fenestrated and branched endovascular aortic repair.
- Author
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Torsello GF, Beropoulis E, Munaò R, Trimarchi S, Torsello GB, and Austermann M
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- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Aortic Aneurysm, Thoracic diagnostic imaging, Aortic Aneurysm, Thoracic mortality, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endoleak etiology, Endoleak therapy, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Prosthesis Design, Retreatment, Retrospective Studies, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Aortic Aneurysm, Thoracic surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Objective: Until today, no dedicated bridging stent graft (BSG) has been available for use in fenestrated and branched endovascular aneurysm repair (F/BEVAR). The purpose of this study was to evaluate the clinical performance of the well-known Advanta/iCast V12 (Getinge Maquet, Rastatt, Germany) and the new Viabahn VBX (W. L. Gore & Associates, Flagstaff, Ariz) balloon-expandable stent graft in F/BEVAR., Methods: Retrospective analysis of prospectively collected data was performed. Inclusion criteria were treatment with fenestrated or branched endografts for complex aortic diseases, implantation of at least one VBX stent graft as a BSG in one of the target vessels, and clinical or radiologic follow-up of 6 months. The primary end point of the study was technical success of all BSGs, defined as placement of the BSG in the desired position with absence of endoleak on final angiography. Secondary end points were freedom from perioperative major adverse events and freedom from reinterventions and mortality at 6 months. Procedural and postoperative data were analyzed., Results: Between December 2017 and July 2018, there were 50 patients (40 male; mean age, 71 years) included. A total of 145 VBX stent grafts were implanted, followed by 57 Advanta V12, 29 Viabahn, and 28 bare-metal stents. There were 126 branches (celiac trunk, 27; superior mesenteric artery, 25; renal arteries, 74) sealed exclusively with VBX. Technical success rate was 98.6%. There were six device-related reinterventions due to type IC endoleaks (n = 4), target vessel stenosis distal to the BSG, and stent graft occlusion in a left renal artery in one case. The perioperative and aneurysm-related mortality was 0%; the 6-month all-cause mortality was 2%., Conclusions: The used BSGs demonstrated promising preliminary results in F/BEVAR. Further evaluation is mandatory to determine durability of the VBX., (Copyright © 2019 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.)
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- 2020
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46. One-Year Results From the SURPASS Observational Registry of the CTAG Stent-Graft With the Active Control System.
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Torsello GF, Argyriou A, Stavroulakis K, Bosiers MJ, Austermann M, and Torsello GB
- Subjects
- Adult, Aged, Aged, 80 and over, Aorta, Thoracic diagnostic imaging, Aorta, Thoracic physiopathology, Aortic Diseases diagnostic imaging, Aortic Diseases mortality, Aortic Diseases physiopathology, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation mortality, Endovascular Procedures adverse effects, Endovascular Procedures mortality, Female, Humans, Male, Middle Aged, Postoperative Complications etiology, Product Surveillance, Postmarketing, Prospective Studies, Prosthesis Design, Risk Factors, Time Factors, Treatment Outcome, Aorta, Thoracic surgery, Aortic Diseases surgery, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Purpose: To report the outcomes from the observational SURPASS registry, which was created to assess the performance of the Conformable TAG (CTAG) stent-graft with the Active Control System (ACS) in patients undergoing thoracic endovascular aortic repair (TEVAR) in a real-world setting. Materials and Methods: The SURPASS registry ( ClinicalTrials.gov ; identifier NCT03286400) was an observational, prospective, single-arm, post-market, international study that enrolled patients undergoing TEVAR using the CTAG with ACS for both acute and chronic thoracic aortic disease between October 2017 and July 2018. The CTAG with ACS features 2-stage deployment of the stent-graft and an optional angulation mechanism that modifies only the proximal end of the stent-graft. During the observation period, 127 patients (mean age 67.1±12.1 years, range 27-86; 92 men) were enrolled and treated for an array of aortic pathologies, including chronic and acute lesions and 4 ruptured descending thoracic aneurysms. The primary outcome of this study was technical success; secondary outcomes were clinical success and major adverse events at 30 days and 12 months. The numbers of 2-stage device deployments and applications of the angulation mechanism were recorded, along with the reasons for use. Results: Technical success of the TEVAR was 97.6% owing to unintentional partial coverage of supra-aortic branches in 3 cases (the vessels were patent on imaging). The stent-graft was repositioned at its intermediate diameter in 79 patients (62.2%), and the angulation feature was applied in 64 cases (50.4%), mainly to improve proximal wall apposition and orthogonality in the aorta. The desired effect was achieved in 60 cases (93.8%). There was no device compression, bird-beak configuration, fracture, or graft occlusion. The 30-day and 12-month clinical success rates were 97.6% and 92.9%, respectively. There were 3 aorta-related deaths at 30 days and a further 3 at 12 months. Fatalities were due to a retrograde type A dissection (0.8%), paraplegia, bowel ischemia, sepsis in the setting of a mycotic aneurysm, aneurysm rupture post aortoesophageal fistula, and multiorgan dysfunction syndrome. Three endoleaks (2 type Ia and 1 type III) required reintervention. Conclusion: In the SURPASS registry, the use of the CTAG device with ACS showed promising outcomes despite the challenging pathologies. The new delivery system enables a controlled staged delivery with in situ adjustments during positioning, facilitating the treatment of complex aortic disease.
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- 2020
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47. Comparison of the Biomechanical Properties of the Advanta V12/iCast and Viabahn Stent-Grafts as Bridging Devices in Fenestrated Endografts: An In Vitro Study.
- Author
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Torsello GF, Herten M, Müller M, Frank A, Torsello GB, and Austermann M
- Subjects
- Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Equipment Failure Analysis, Foreign-Body Migration etiology, Materials Testing, Prosthesis Design, Prosthesis Failure, Risk Factors, Stress, Mechanical, Blood Vessel Prosthesis, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures instrumentation, Stents
- Abstract
Purpose: To compare experimentally the biomechanical properties of the Viabahn Balloon-Expandable Stent Graft (VBX) with the widely used Advanta V12/iCast in the role of bridging stent-grafts for fenestrated endovascular aortic repair. Materials and Methods: Test sheets made of polyester having 2 rows of 5 fenestrations in 6-mm and 8-mm diameters were used to simulate a commercially made fenestrated aortic endograft. In total, 40 stent-grafts measuring 6×39 mm and 8×39 mm (10 of each size for each stent-graft) were implanted in fenestration sheets immersed in a 37°C water bath. After flaring, all stent-grafts were evaluated using microscopy and radiography. Biomechanical evaluation included pullout and the shear stress force testing; results are reported in Newtons (N) as the median (minimum-maximum). Results: After flaring, no damage or fracture to the stent-graft structures were detected. Pullout forces for the 6-mm stent-grafts were 27.1 N (20.0-28.9) for the VBX and 16.6 N (14.7-19.2) for the Advanta (p=0.008). Pullout forces for the 8-mm stent-grafts were 20.1 N (14.8-21.5) for the VBX and 15.8 N (12.4-17.5) for the Advanta (p=0.095). The shear stress forces necessary to dislocate the device at 150% stent diameter displacement was 12.5 N (VBX) vs 14.7 N (Advanta) for the 6-mm devices and 23.3 N (VBX) vs 20.2 N (Advanta) for the 8-mm stents (p>0.99 and p=0.222, respectively). Conclusion: In vitro tests simulating external pull and shear forces on bridging stent-grafts implanted in fenestrations showed that the VBX had resistance to dislocation equivalent to a well-known control device.
- Published
- 2020
- Full Text
- View/download PDF
48. Longer bridging stent-grafts in iliac branch endografting does not worsen outcome and expands its applicability, even in concomitant diseased hypogastric arteries.
- Author
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Bosiers MJ, Panuccio G, Bisdas T, Stachmann A, Donas KP, Torsello G, and Austermann M
- Subjects
- Aged, Aged, 80 and over, Aortic Aneurysm, Abdominal diagnostic imaging, Aortic Aneurysm, Abdominal mortality, Aortography methods, Blood Vessel Prosthesis, Comorbidity, Databases, Factual, Female, Humans, Iliac Artery surgery, Male, Middle Aged, Patient Safety, Prognosis, Retrospective Studies, Risk Assessment, Stents, Treatment Outcome, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation instrumentation, Endovascular Procedures methods, Prosthesis Design, Vascular Patency physiology
- Abstract
Background: The iliac side branch device (IBD) is a valid method for the treatment of abdominal aorto-iliac aneurysms. However there is still a lack of evidence regarding the optimal length of the bridging stent graft (BSG) since aneurysmal degeneration of the hypogastric artery (HA) is an exclusion criterion. The aim of this study was to analyse the impact of longer BSG compared to the widely used 38mm stent-grafts in terms of reintervention rate and primary patency., Methods: We retrospectively analyzed our prospectively collected database of all patients who underwent an endovascular aneurysm repair using an IBD in our center between April 2005 and May 2015. The used BSGs were divided into 2 groups. In group A, the BSG was ≤38 mm, and group B>38 mm. The primary endpoint was BSG-related events, including stenosis, occlusion or endoleak. Secondary endpoints were technical success, primary patency and 30-day mortality., Results: Two hundred sixty IBDs were implanted in 215 consecutive patients. Ninetyseven (37%) in group A and 163 (63%) in group B. The technical success rate was 100%. The 30-day mortality was 1% (N.=1) and 1.2% (N.=2) respectively for group A and B (P=0.8). The freedom from BSG-related events amounted to 84% at 60 months for the total cohort. The comparison between the two groups shows no significant difference, while a slight favorable trend for group B (75% vs. 91% at 60 months, P=0.081) was observed. No differences were found as to primary patency (96% and 99% at 60 months respectively for group A and B, P=0.237)., Conclusions: The use of longer stent-grafts (>38 mm) seems not to affect the performance of BSG even in the long run, expanding the indication for IBD also for aneurysms of the hypogastric artery.
- Published
- 2020
- Full Text
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49. Cost-effectiveness analysis of chimney/snorkel versus fenestrated endovascular repair for high-risk patients with complex abdominal aortic pathologies.
- Author
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Taneva GT, Donas KP, Pitoulias GA, Austermann M, Veith FJ, and Torsello G
- Subjects
- Aortic Aneurysm, Abdominal diagnostic imaging, Blood Vessel Prosthesis Implantation adverse effects, Blood Vessel Prosthesis Implantation instrumentation, Cost-Benefit Analysis, Endovascular Procedures adverse effects, Endovascular Procedures instrumentation, Humans, Patient Readmission economics, Postoperative Complications economics, Postoperative Complications surgery, Prosthesis Design, Reoperation economics, Time Factors, Treatment Outcome, Aortic Aneurysm, Abdominal economics, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis economics, Blood Vessel Prosthesis Implantation economics, Endovascular Procedures economics, Hospital Costs
- Abstract
Background: The aim of this study was to evaluate the cost-effectiveness of chimney (ch-EVAR) vs. fenestrated aneurysm repair (f-EVAR) for treatment of complex abdominal aortic pathologies. Endovascular repair of complex abdominal aortic pathologies with involvement of renal arteries includes use of f-EVAR as first line treatment. However, lack of availability and suitability has necessitated an alternative strategy employing parallel or snorkel/chimney grafts (ch-EVAR)., Methods: Between January 2013 and January 2017, prospectively collected data of elective and symptomatic patients with complex aortic pathologies treated by single or double ch-EVAR (N.=111) or by f-EVAR with three fenestrations (N.=37) were evaluated. The primary endpoint was cost-effectiveness analysis defined as the summary of material costs, in-hospital costs and additional costs due to procedure-related reinterventions during a follow-up period averaging 37.2 months., Results: No differences between both groups were found in terms of demographics (P=0.32), age (P=0.058) and hospital stay at initial procedure (P=0.956). Index procedure and hospitalization median costs were € 22,171 for ch-EVAR and € 42,116 for f-EVAR, respectively (P<0.001). The median overall costs including costs after reinterventions during follow-up were € 22,872 for ch-EVAR and € 42,128 for f-EVAR (P<0.001). Six patients (5.4%) in the ch-EVAR group required readmission compared to three patients (8.1%) required readmission for reinterventions in the f-EVAR group (P=0.69)., Conclusions: Ch-EVAR is significantly more cost-effective compared to f-EVAR. The two procedures have comparable readmission rates for reinterventions.
- Published
- 2020
- Full Text
- View/download PDF
50. FEVAR: is still the preferred therapeutic option for juxtarenal aortic aneurysms?
- Author
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Donas KP, Fazzini S, Austermann M, Gargiulo M, Gallitto E, and Torsello G
- Subjects
- Blood Vessel Prosthesis Implantation adverse effects, Endovascular Procedures adverse effects, Humans, Aortic Aneurysm, Abdominal surgery, Blood Vessel Prosthesis Implantation methods, Endovascular Procedures methods
- Published
- 2020
- Full Text
- View/download PDF
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